Study Stopped
The study was halted prematurely due to low enrollment and anticipation of future barriers to enrollment.
Prospective Evaluation of Interscalene Nerve Catheters vs. Single Injection Blocks
Continuous Interscalene Block (CISB) Versus Single Injection Interscalene Block in Those Undergoing Shoulder Surgery in the Ambulatory Setting
1 other identifier
interventional
73
1 country
2
Brief Summary
The primary hypothesis is that those patients who choose an interscalene catheter will have less pain postoperatively than those with single injection blocks. Secondary hypotheses examine physical therapy outcomes and incidence of parasthesia or pain following surgery for up to 3 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable pain
Started Jun 2011
Longer than P75 for not_applicable pain
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 28, 2011
CompletedFirst Posted
Study publicly available on registry
June 30, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedFebruary 18, 2019
February 1, 2019
4.7 years
June 28, 2011
February 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
pain on post-operative day 1
Pain score on post-operative day 1(POD1) using numeric rating scale (NRS)
24 hours
Secondary Outcomes (1)
Pain post operative day 2 (POD2)
48 hours
Study Arms (2)
interscalene block
EXPERIMENTALinterscalene block
interscalene catheter
EXPERIMENTALinterscalene catheter
Interventions
Eligibility Criteria
You may qualify if:
- American Society of Anesthesiologists (ASA) physical status 1-3
- years of age, inclusive
- body mass index of \< 36 kg/m2.
- The ability to understand local anesthetic related complications and care of a CPNB
- Presence of a caretaker with them during the first 24 hours of local anesthetic infusion, and on a daily basis.
- The ability to communicate with the practitioner managing the catheter.
- Residence within 2 hours of University of Wisconsin Hospital and Clinics
You may not qualify if:
- Any contraindication to a continuous interscalene catheter placement
- Clinically significant pulmonary disease
- Clinically significant cardiac disease
- Allergy to ropivacaine
- Peripheral or central nervous system disease
- Current (or planned) anticoagulation therapy or disease
- Local infection over area of catheter placement
- Renal or hepatic failure
- History of opioid dependence
- Significant psychiatric disease
- Pregnancy or lactation (Subjects will be asked if it is possible they could be pregnant. If a subject responds in the affirmative, a pregnancy test will be done.)
- Seizure Disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
U of Wisconsin
Madison, Wisconsin, 53705, United States
University of Wisconsin
Madison, Wisconsin, 53705, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2011
First Posted
June 30, 2011
Study Start
June 1, 2011
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
February 18, 2019
Record last verified: 2019-02